CHMP recommends Giotrif (Boehringer) for NSCLC

On 25 July 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Giotrif 20 mg, 30 mg, 40 mg and 50 mg film-coated tablets from Boehringer, intended for the treatment of EGFR TKI-na�ve adult patients with locally advanced or metastatic Non-Small Cell Lung Cancer with activating EGFR mutation(s).

The benefits with Giotrif have been shown in a phase III, randomised, open-label study of afatinib versus chemotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with activating EGFR mutation(s). In this study efficacy has been shown in terms of an increased progression free survival in patients receiving afatinib compared to chemotherapy. The most common side effects are diarrhea, stomatitis, rash, dermatitis acneiform, pruritus, dry skin, paronychia, decreased apetite and epistaxis. A pharmacovigilance plan for Giotrif will be implemented as part of the marketing authorisation.